Summary

To examine the impact of cognitive-behavioural therapy on both the episodic and functional
outcome of bipolar disorder, in combination with pharmacotherapy.

Primary Hypothesis is twofold:

1. Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by
percentage of time spent ill (both syndromic and subsyndromal) and number of episodes,
as compared to psychoeducation

2. Cognitive behavioural therapy will reduce social and occupational disability to a
greater extent than psychoeducation.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria:
1. Bipolar I or II
2. Currently either in remission or subsyndromally ill (Hamilton Depression Scale-17<14;
Clinician Administered Rating Scale for Mania<12).
3. Age eighteen to sixty.
4. Significant symptoms and/or episodes on at least two occasions in the past three
years.
5. Grade six education, able to understand English, and Folstein Minimental Score Exam >
26 to ensure cognitive ability to participate.
6. On mood-stabilizing medication.
Exclusion Criteria:
1. Substance dependence meeting Diagnostic and Statistical Manual of Mental Disorders-IV
criteria within the last three months.
2. Acutely highly suicidal or homicidal.
3. Serious other medical condition that would render pharmacotherapy or psychotherapy
very difficult such as cancer, severe diabetes, etc.
4. Severe antisocial or borderline personality disorder (personality disorder per se is
not exclusionary). Subjects may have other axis I disorders, but bipolar disorder
must be the principal disorder requiring treatment.

Additional Information

Objective:
To compare the impact of cognitive -behavioral therapy to that of properly structured psycho
education on the 'illness burden' and functional outcome of bipolar disorder, in combination
with pharmacotherapy.
Interventions:
Subjects will be randomized to either a "control" treatment group cosisting of 6 sessions of
group psycho-education (topics include illness recognition, treatment approaches, and
monitoring and coping strategies; based on manual by Bauer & McBride, 2002: Life Goals Phase
I) or they will be randomized to the "experimental" treatment group: 20 sessions of
individual Cognitive Behavioural Therapy for Bipolar Disorder (topics include limited
psychoeducation, activity scheduling/behavioural interventions, cognitive techniques,
including thought monitoring and challenges to dysfunctional assumptions and other coping
techniques; based on manual by Lam et al., 1999: Cognitive Therapy for Bipolar Disorder)

Trial information was received from ClinicalTrials.gov and was last updated in September 2005.

Information provided to ClinicalTrials.gov by University Health Network, Toronto.